Abstract

Background

Regional pain in the hip in adults is a common cause of a general practitioner visit.
A considerable part of patients suffer from (greater) trochanteric pain syndrome or
trochanteric bursitis. Local corticosteroid injections is one of the treatment options.
Although clear evidence is lacking, small observational studies suggest that this
treatment is effective in the short-term follow-up. So far, there are no randomised
controlled trials available evaluating the efficacy of injection therapy.

This study will investigate the efficacy of local corticosteroid injections in the
trochanter syndrome in the general practice, using a randomised controlled trial design.
The cost effectiveness of the corticosteroid injection therapy will also be assessed.
Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid
injections will be investigated.

Methods/Design

This study is a pragmatic, open label randomised trial.

A total of 150 patients (age 18–80 years) visiting the general practitioner with complaints
suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid
injections or to receive usual care. Usual care consists of analgesics as needed.
The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis
of the hip, or both. The treatment will be evaluated by means of questionnaires at
several time points within one year, with the 3 month and 1 year evaluation of pain
and recovery as primary outcome. Analyses of primary and secondary outcomes will be
made according to the intention-to-treat principle. Direct and indirect costs will
be assessed by questionnaires. The cost effectiveness will be estimated using the
following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect
of injection therapy minus effect of usual care).

Discussion

This study design is appropriate to estimate effectiveness and cost-effectiveness
of the injection therapy. We choose to use a pragmatic study design and are thus not
able to study specific effects of the injection with corticosteroids. A distinction
between placebo effect of the injection and specific effects of the corticosteroids
is therefore not possible.

Trial Registration

The trial is listed in the Dutch Trial Registry with the number ISRCTN16994576